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FDA Greenlights Jazz Pharmaceutical's Xywav for Idiopathic Hypersomnia

FDA approves first of its kind indication for chronic sleep disorder treatment

The U.S. Food and Drug Administration on August 12 grants approval to a new indication for Xywav for idiopathic hypersomnia (IH) in adults. IH is a rare chronic sleep disorder that triggers excessive sleepiness in people during the day even after a good night's sleep. Xywav (potassium, calcium, magnesium, and sodium oxybates) oral solution has already been approved for the treatment of cataplexy or excessive daytime sleepiness in patients seven years or older with narcolepsy.

"A novel indication for Xywav is significant as the FDA has never approved for idiopathic hypersomnia," noted Eric Bastings, M.D., deputy director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research.

“Idiopathic hypersomnia is a life-long condition, and the approval of Xywav will be instrumental in providing treatment for symptoms such as excessive sleepiness and difficulty waking, and in effectively managing this deliberating disorder.”

The efficacy of Xywav was evaluated in a double-blind placebo-controlled randomized-withdrawal study in 154 adult patients (ages 19 to 75 years) with IH. In the clinical study, individuals who were randomized to change from Xywav to placebo experienced worse sleepiness and symptoms of IH in comparison to individuals randomized to continue treatment with Xywav.

In the clinical trial for IH, the prevalent adverse events based on the result of the treatment observed in the study included anxiety (10.4%), vomiting (10.4%), dizziness (11.7%), headache (16.2%), and nausea (21.4%).

Xywav includes a boxed warning for central nervous system depression and abuse and misuse. The active moiety of Xywav is oxybate, also referred to as gamma-hydroxybutyrate (GHB), a Schedule I controlled substance. Abuse or misuse of prohibited GHB has been linked with chronic side effects such as coma, seizures, changes in alertness, difficulty in breathing, and death. Clinically significant respiratory depression and decreased level of alertness have taken place in adult patients on sodium oxybate.

Due to the possible risks linked with Xywav, it is subject to rigorous safety controls on prescribing and dispensing under a program known as a Risk Evaluation and Mitigation Strategy (REMS).

In specific terms, under the Xywav REMS, it can be prescribed only by a certified doctor or physician and sold only to an enrolled patient by a certified pharmacy. Only a certified pharmacy that delivers directly to patients can sell Xywav. Xywav will not be offered in retail pharmacies.

The FDA approved this application under the Fast Track and Priority Review. Xywav was also granted Orphan Drug designation, which offers incentives to assist and aid the development of drugs for uncommon diseases. The FDA granted the approval of Xywav to Jazz Pharmaceuticals plc.

N:B: Combining XYWAV with other central nervous systems (CNS) depressants such as drugs used to inhibit sleep in you or your child, including antipsychotics, benzodiazepines, general anesthetics, sedating antidepressants, muscle relaxants, antipsychotics, street drugs, or alcohol, may bring about severe health issues, including difficulty in breathing, drowsiness, low blood pressure, fainting, and death.